← Back to Search

Tranexamic Acid for Spinal Deformity

Phase 3

Recruiting

Led By Han Jo Kim, MD

Research Sponsored by Hospital for Special Surgery, New York

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18-80

Scheduled to undergo posterior long segment (≥ 5 levels) posterior spinal fusion for adult scoliosis or degenerative joint disease + fusion to pelvis

Must not have

Diagnosis of seizure disorder or prior seizure

Presence or history of dural tear without repair as evidenced by pseudomeningocele on MRI imaging or by intraoperative exploration

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 72 hours postoperatively

Awards & highlights

Pivotal Trial

All Individual Drugs Already Approved

Summary

This trial is testing whether using tranexamic acid (TXA) both intravenously and topically can decrease blood loss and transfusion requirements in adult patients compared to using TXA intravenously alone during posterior spinal surgery for adult deformity.

Who is the study for?

Adults aged 18-80 scheduled for long spinal fusion surgery due to scoliosis or degenerative joint disease, who are not on certain blood thinners, without recent heart issues, bleeding disorders, severe anemia, color vision problems, active cancer or leukemia. They mustn't have renal or liver insufficiency, seizure history or thromboembolic events within the past year.

What is being tested?

The trial is testing if Tranexamic Acid (TXA), used topically as an add-on to its intravenous form can reduce blood loss and need for transfusions during adult spine deformity surgeries. It compares the effectiveness of topical TXA with a placebo in patients already receiving intravenous TXA.

What are the potential side effects?

Tranexamic Acid may cause side effects such as nausea, diarrhea, seizures in rare cases especially in individuals with a history of seizures; it could also increase the risk of developing blood clots.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 80 years old.

Select...

I am scheduled for a major spine surgery for scoliosis or joint disease, including fusion to the pelvis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have been diagnosed with a seizure disorder or have had a seizure before.

Select...

I have had a dural tear that was not repaired, confirmed by MRI or surgery.

Select...

I have donated my own blood before surgery.

Select...

I have kidney or liver problems.

Select...

I have leukemia or another active cancer.

Select...

I cannot stop my blood thinner medication for surgery.

Select...

I have a condition that causes my blood to clot more than normal.

Select...

I have atrial fibrillation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 72 hours postoperatively

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 72 hours postoperatively

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 72 hours postoperatively for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Postoperative Drain output

Secondary study objectives

Length of stay

Perioperative adverse events

Perioperative blood drop

+1 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ivTXA + topical TXAExperimental Treatment1 Intervention

TXA lavage solution (200 cc sterile normal saline + 5 g tranexamic acid 100mg/ml (50cc)) will be poured into the surgical field and left in contact for five minutes. This will occur after instrumentation. Excess solution will be suctioned away using a non-cell saver suction. IV txa will be given as (5mg/ml) loading dose (20mg/kg) over 15 minutes followed by 2 mg/kg/hr maintenance dosing as per hospital protocol

Group II: IV TXA + topical placeboPlacebo Group1 Intervention

Placebo solution (200 cc sterile normal saline + placebo TXA ampule (normal saline) (50cc)) will be poured into the surgical field and left in contact for five minutes. This will occur after pedicle screw instrumentation. Excess solution will be suctioned away using a non-cell saver suction. IV txa will be given as (5mg/ml) loading dose (20mg/kg) over 15 minutes followed by 2mg/kg/hr maintenance dosing as per hospital protocol

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tranexamic acid

FDA approved

0 / 10Eligibility criteria met